Source: Hong Kong Government special administrative region
The Department of Health (DH) announced today (June 26) the timetable for establishing the Hong Kong Centre for Medical Products Regulation (CMPR) and the roadmap for implementing “primary evaluation”. The CMPR will be established by the end of next year (2026), and the DH will implement “primary evaluation” for new drug registration in phases beginning next year, with full implementation by 2030. These developments mark a significant milestone in Hong Kong’s transformation into an international health and medical innovation hub.
The Director of Health, Dr Ronald Lam, said, “The Hong Kong Special Administrative Region (HKSAR) Government is committed to raising regulatory standards for medical products in Hong Kong. With the establishment of the CMPR, we will consolidate regulatory functions for Western and Chinese medicines, as well as medical devices, and enhance the existing regulatory regime in a holistic manner. The vision of the CMPR is to become a “leading, internationally renowned medical products regulatory authority, driving excellence and innovation”, with the goal of gaining international recognition in the field. The CMPR will promote innovation, and research and development (R&D) of drugs and devices by optimising medical products regulation. This will ensure that the public can benefit from the latest scientific research, and that patients will gain earlier access to innovative, safe and effective medical products. It also fosters growth in the local healthcare and biotechnology industries.”(2) continuously enhance professional capacity, strengthen regulatory efficiency, and implement “primary evaluation” in phases;
(3) deepen collaboration with local, Mainland and overseas stakeholders and regulatory authorities, strive for international recognition, and foster an innovation-friendly environment; and
(4) further optimise the regulation of Chinese medicine based on the Chinese Medicine Development Blueprint to be published by the Health Bureau in the fourth quarter of this year, leveraging the HKSAR’s role as a national bridgehead for the internationalisation of Chinese medicine.